Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092332
Device Classification Name
Catheter, Peripheral, Atherectomy
More FDA Info for this Device
510(K) Number
K092332
Device Name
Catheter, Peripheral, Atherectomy
Applicant
PATHWAY MEDICAL TECHNOLOGIES, INC.
10801 120TH AVENUE NE
KIRKLAND, WA 98033 US
Other 510(k) Applications for this Company
Contact
BRIAN CLEARY
Other 510(k) Applications for this Contact
Regulation Number
870.4875
More FDA Info for this Regulation Number
Classification Product Code
MCW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2009
Decision Date
09/03/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact